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NCT Number: NCT06742437

Efficacy and Safety of a New Sperm Capacitation Method

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.

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Key information

Conditions

Reproductive Issues Asthenozoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Infertility Male Urogenital Diseases Oligospermia Oligozoospermia Teratozoospermia Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

CIRH, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide a semen sample via masturbation

Exclusion criteria

  • Current diagnosis of a sexually transmitted infection (STI)
  • Previous diagnosis of hepatitis A, B, C, D, or HIV
  • Prior participation in this study
  • Participation in a clinical trial involving an intervention within the last 3 months

Treatment and study plan

Standard sperm preparation

Device

Sperm samples in the control group will undergo traditional processing

HyperSperm

Device

Sperm samples in the experimental group will undergo product-specific processing

Primary outcomes

  1. Hyperactivation

    Time frame: 2 hours

    Percentage of sperm cells displaying hyperactivated motility

Secondary outcomes

  1. Sperm vitality

    Time frame: 2 hours

    Percentage of viable sperm cells

  2. DNA fragmentation

    Time frame: 2 hours

    Percentage of TUNEL-positive sperm cells

  3. Sperm motility

    Time frame: 2 hours

    Percentage of motile sperm cells

  4. Survival

    Time frame: 20 hours

    Percentage of motile sperm cells after overnight incubation

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Gomez Elias, PhD

CONTACT

[email protected]

+34624174355

Sponsors and collaborators

Lead sponsor

Fecundis Lab SL

Other

Registry information

Official study title

Efficacy and Safety of a New Sperm Capacitation Method: a Prospective in Vitro Study on Semen Samples

Acronym: HyperSperm01

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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